IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial

Inclusion Criteria:

1. Females 18-75 years of age.

2. Patients must have metastatic, recurrent or persistent gastric-type adenocarcinomaof the cervix which is not amenable to curative treatment with surgery and/orradiation therapy.

3. Patients must have had at least one prior systemic chemotherapeutic regimen formetastatic, recurrent or persistent carcinoma of the cervix. (Note: Prior adjuvanttherapy is NOT counted as a systemic chemotherapeutic regimen for management ofmetastatic, recurrent or persistent carcinoma of the cervix, adjuvant therapyincludes cisplatin given concurrent with primary radiation therapy (CCRT).

4. Patients must have measurable disease per REClST 1.1; measurable lesions are definedas those that can be accurately measured in at least one dimension (longest diameterto be recorded as ≥ 10 mm with computed tomography (CT) scan, magnetic resonanceimaging (MRI); a lymph node must be ≥ 15 mm in short axis.

5. Eastern Cooperative Oncology Group score 0-1.

6. Life expectancy exceeds 3 months.

7. AEs due to previous treatments should be resolved to ≤ Grade 1 or baseline.Participants with ≤ Grade 2 neuropathy are eligible.

8. NEU ≥ 1.5*10^9 /L, Platelet ≥ 75×10^9 /L, Hemoglobin ≥ 90 g/L; Serum creatinine ≤ 1.5 times the upper limit of normal (ULN).; Urinary protein < 2+ or 24h urinaryprotein quantity < 1.0 g; AST and ALT ≤ 2.5 times ULN; Total bilirubin ≤ 1.5 timesULN; Albumin levels ≥ 28 g/L; Coagulation function: Prothrombin time (PT) andinternational normalized ratio (INR) ≤ 1.5 times the ULN.

9. Female participants must test negative for HCG in urine or blood, except in cases ofmenopause or prior hysterectomy. Female patients of childbearing potential and theirpartners must use effective contraception during the study and for 6 months afterthe final dose of the study drug.

10. Willing to participate in this study, and sign the informed consent.

Exclusion Criteria:

1. Patients with cervical cancer histologically diagnosed as squamous cell carcinoma,usual-type adenocarcinoma, clear cell carcinoma, adenosquamous carcinoma, small cellcarcinoma, or any non-gastric-type adenocarcinoma.

2. Participate in other drug clinical trials at the same time.

3. Known hypersensitivity to any component of the IN10018 formulation or tocadonilimab.

4. Patients with active autoimmune disease or a history of autoimmune disorders.

5. Patients with concomitant conditions requiring immunosuppressive medications orsystemic or absorbable local corticosteroids at immunosuppressive doses. The use ofprednisone >10 mg/day or an equivalent dose is prohibited within 2 weeks prior tothe first administration of the investigational drug.

6. HIV infection or a positive test for acquired immunodeficiency syndrome (AIDS).

7. Patients with a history of allogeneic organ transplantation or allogeneichematopoietic stem cell transplantation.

8. Necrotic lesions identified within 4 weeks prior to enrollment, where there is ahigh risk of major bleeding as determined by the investigator.

9. Severe infections occurring within 4 weeks prior to the first dose of studytreatment.

10. Known active tuberculosis (TB) or suspicion of active TB.

11. Untreated chronic hepatitis B infection or hepatitis B virus (HBV) carriers with HBVDNA levels exceeding 1000 IU/mL, or patients with active hepatitis C infection.

12. Patients with known leptomeningeal disease, spinal cord compression, or active brainmetastases.

13. Uncontrolled severe medical conditions that, in the investigator's judgment, wouldinterfere with the patient's ability to receive study treatment, including but notlimited to severe cardiovascular disease, cerebrovascular disease, uncontrolleddiabetes, or uncontrolled infections.

14. Receipt of a live vaccine within 4 weeks prior to the first dose of study treatment.Note: Inactivated seasonal influenza vaccines are permitted.

15. Pregnant or breastfeeding female patients, or female patients of childbearingpotential who refuse to use effective contraception.

16. Patients with symptomatic or unstable third-space fluid accumulations (e.g., pleuraleffusion, ascites, pericardial effusion) requiring repeated drainage.

17. Patients with a prior genetic test report indicating mutations associated withhyperprogression under immunotherapy, such as MDM2/4 amplification or EGFRmutations.

18. Not eligible for the study judged by researchers.